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Wed, September 06, 2006 10:23:08 PMFrom:
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Subject:
DrugLinx : Drug Trials Newsletter 09/06/2006 10:21PM
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| MDLinx.com > DrugLinx > News | Wednesday, Sep 6, 2006 | ||||||||
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Extensive Post-License Data Reaffirm Clinical Safety Profile of Prolastin(R) Sales and Marketing Network The largest safety data set among alpha-1 antitrypsin augmentation (AAT) therapies compiled over the longest period of time reaffirms the clinical safety and tolerability of Prolastin (Alpha1-Proteinase Inhibitor (Human)) in treating patients with AAT deficiency. Presented at the 2006 Annual Congress of the European Respiratory Society, safety data collected since the original approval of Prolastin in 1987 now represent more than 18 years of clinical experience and 40,826 patient-years of exposure... Free Full Text Arformoterol Study Data Presented at European Respiratory Society Annual Congress Sales and Marketing Network Sepracor Inc. announced that it presented a poster of pooled data from Phase III trials of arformoterol tartrate inhalation solution at the 16th Annual Congress of the European Respiratory Society (ERS) in Munich, Germany. Arformoterol tartrate inhalation solution is a long-acting beta-agonist formulation proposed for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema... Free Full Text GlaxoSmithKline and Adolor Report Top-Line Results From Phase 3 Studies of Alvimopan (Entereg/Entrareg(R)) Sales and Marketing Network GlaxoSmithKline and Adolor Corporation announced top-line results from two identically designed Phase 3 registration studies (012 and 013) of alvimopan (Entereg/Entrareg) for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic non-cancer pain. Study 012 achieved statistical significance in its primary endpoint... Free Full Text GTx's Phase III Clinical Development of ACAPODENE on Course Following Planned Safety Review Sales and Marketing Network GTx, Inc., the Men's Health Biotech Company, announced that a per protocol interim safety review by an independent Drug Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III trials of ACAPODENE (toremifene citrate). The DSMB meets regularly every six months to review unblinded safety data from the two pivotal Phase III clinical trials... Free Full Text Nuvelo Announces Completion of Patient Enrollment in NAPA-2, First Phase 3 Trial of Alfimeprase in Acute Peripheral Arterial Occlusion Sales and Marketing Network Nuvelo, Inc. announced that it has completed patient enrollment in the first Phase 3 clinical trial of alfimeprase for the treatment of acute peripheral arterial occlusion (PAO), or "leg attack." The Phase 3 trial, known as NAPA-2 (Novel Arterial Perfusion with Alfimeprase-2), is the first of two multi-national trials in the Phase 3 alfimeprase program for acute PAO... Free Full Text Nuvelo Announces Completion of Patient Enrollment in SONOMA-2, First Phase 3 Trial of Alfimeprase in Central Venous Catheter Occlusion Sales and Marketing Network Nuvelo, Inc. announced that it has completed patient enrollment in the first Phase 3 clinical trial of alfimeprase for the treatment of central venous catheter occlusion (CO). The Phase 3 trial, known as SONOMA-2 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-2), is the first of two ongoing, multi-national trials in the Phase 3 alfimeprase program for CO... Free Full Text September 5, 2006New Lipitor Data Published in The Lancet Sales and Marketing Network Lipitor Reduces Risk of Major Cardiovascular Events Such as Heart Attacks in People With Heart Disease and With a Cluster of Other Major Cardiovascular Risk Factors, Often Referred to as Metabolic Syndrome, New Analysis Shows Heart Disease Patients With Metabolic Syndrome who Took Lipitor 80mg Dose Reduced Their Risk of Major Cardiovascular Events by Nearly 30 Percent... Free Full Text New Study Reveals Investigational 24-Hour Formulation of Requip(R) (ropinirole HCl) Tablets Reduced "Off" Time for Patients With Parkinson's Disease Sales and Marketing Network The addition of investigational Requip (ropinirole HCl) extended-release tablets to Parkinson's patients existing therapy delayed "off" time - a well-known phenomenon in which symptoms return as patients' medication wears off - by an average of more than two hours per day when compared to placebo, according to new data presented at the annual European Federation of Neurological Societies Congress.... Free Full Text New Data from Vasogen's ACCLAIM Trial in Heart Failure Presented at World Congress of Cardiology 2006 Sales and Marketing Network Vasogen Inc., a leader in the research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease, announced that new data from the 2,400-patient ACCLAIM trial in chronic heart failure showed that in a major combined subgroup of New York Heart Association (NYHA) Class III/IV patients with no prior history of heart attack and all Class II patients, together comprising more than 50% of the study population, Vasogen's Celacade(TM) technology reduced the risk of death and cardiovascular hospitalization by 31% (n= 1,305 patients, p=0.0003)... Free Full Text | ||||||||||||||||||||||
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